VISIONIX

GUDID 03664188001180

The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.

LUNEAU SAS

Optical pachymeter

• Primary Device ID: 03664188001180
• NIH Device Record Key: 6b66459d-1d4b-44ee-963b-90d4a3b8be28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONIX
• Version Model Number: VX118
• Company DUNS: 275362465
• Company Name: LUNEAU SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664188001180 [Primary]

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-23

On-Brand Devices [VISIONIX]

• 03664188001203: The VX120 is a multifunctional eye diagnostic device. There are several operation modes combined
• 03664188001180: The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined